DETERMINATION OF DOSAGES; UNSEALED RADIOACTIVE MATERIAL

A. A licensee must determine and record the activity of each dosage before medical use. B. For a unit dosage, the determination under item A must be made by: (1) direct measurement of radioactivity; or (2) a decay correction, based on the activity or activity concentration determined by: (a) a manufacturer or preparer licensed under part 4731.3395 or equivalent requirements of the NRC or an agreement state; (b) an NRC or agreement state licensee for use in research according to the radioactive drug research committee-approved protocol or an investigational new drug protocol accepted by the Food and Drug Administration; or (c) a PET radioactive drug producer licensed according to part 4731.3065 , subpart 7, or equivalent requirements of the NRC or an agreement state. C. For other than unit dosages, the determination under item A must be made by: (1) direct measurement of radioactivity; (2) a combination of measurement of radioactivity and mathematical calculations; (3) a combination of volumetric measurements and mathematical calculations, based on the measurement made by a manufacturer or preparer licensed under part 4731.3395 or equivalent requirements of the NRC or an agreement state; or (4) a PET radioactive drug producer licensed according to part 4731.3065 , subpart 7, or equivalent requirements of the NRC or an agreement state. D. Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent. E. A licensee must retain a record of the dosage determination required under this part according to part 4731.4503 .